Product Classification

• Device: sterilization wrap containers, trays, cassettes & other accessories
• Regulation Description: Sterilization wrap.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: KCT
• Premarket Review: Office of Surgical and Infection Control Devices (OHT4); Infection Control Devices (DHT4C)
• Submission Type: 510(k)
• Regulation Number: 880.6850
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 14-396 ANSI AAMI ST77:2013/(R)2018
  Containment devices for reusable medical device sterilization
• 14-601 ISO 17665 First edition 2024-03
  Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• aabb
• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc